US: FDA gives emergency approval for Moderna Covid vaccine
Moderna Inc’s coronavirus vaccine on Friday became the second to receive emergency use authorization from the US Food and Drug Administration (FDA), welcome news to a nation with a staggering Covid-19 death toll of over 307,000 lives lost.
Millions of doses of the Moderna vaccine are expected to be added to the US rollout; which began this week with healthcare workers. Older people in long-term care facilities are next in line for vaccines, with a US Centres for Disease Control and Prevention expert panel on Sunday set to recommend what groups follow, as industries compete to have their workers given precedence.
The FDA announced the authorization the day after the agency’s panel of outside experts endorsed its use and a week after the FDA authorized a vaccine from Pfizer Inc and German partner BioNTech SE.
The vaccine from Pfizer and BioNTech, based on similar technology; has been put into the arms of thousands of US healthcare workers this week in a massive nationwide rollout. Moderna injections are expected to begin in the coming days for adults 18 years old and up.
“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen Hahn, MD, said in a statement.
Moderna’s shot is expected to be used in harder-to-reach locations, such as rural hospitals. The vaccine needs to be stored and shipped frozen but does not require the ultra-cold temperatures of the Pfizer/BioNTech shot.
The speed of vaccine development — less than a year from when the first case of the new coronavirus was found in the United States — is a stunning scientific success; although there is some hesitancy among the public.
“It is my hope that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward,” top US infectious disease scientist Anthony Fauci said in a statement.
Moderna said it intended to apply for a full US license in 2021.
The FDA decision marks the first regulatory authorization in the world for Moderna’s vaccine and validation of its messenger RNA technology; shown to be nearly 95 percent effective with no serious safety concerns. It comes less than a year after the first Covid-19 case was identified in the United States.
The vaccine, developed in partnership with the National Institutes of Health; had relatively minor side effects including pain around the injection site and swelling.
The biotech company has worked with the US government to prepare for the distribution of 5.9 million shots; starting as early as this weekend.
Once thawed, the Moderna vaccine can be kept at typical refrigerator temperatures. It is administered in two shots 28 days apart.
US President Donald Trump on Twitter hailed the authorization. “Congratulations, the Moderna vaccine is now available!” he wrote.
Congratulations, the Moderna vaccine is now available!
— Donald J. Trump (@realDonaldTrump) December 19, 2020
